Pharmacy cold chain monitoring for TMDA GSDP
Pharmacy cold chain monitoring keeps a continuous temperature record for the fridges and cold rooms that hold medicines, vaccines and biologics. Trakora watches every reading against a set band, raises an excursion alert when it goes too warm and a freeze alert when it goes too cold, and flags the moment a probe stops reporting — so the storage record an auditor asks for is complete.
Pharmacy cold chain monitoring at a glance
- What it monitors
- Pharmacy fridges & cold rooms
- Rules it owns
- temp_above_threshold · temp_below_threshold · sensor_offline
- Also monitored
- Humidity — charted, no alarm rule
- Temperature band
- —1 set per product / store
- Reporting interval
- —1 tuned per deployment
- Alert channels
- SMS · WhatsApp · push
- Reporting output
- Compliance report per store / period
- Regulatory framing
- TMDA Good Storage & Distribution Practice
- Who it's for
- Pharmaceutical distributors, wholesale & hospital pharmacies
Excursion, freeze and a broken record
A cold chain fails in three ways an auditor cares about: it got too warm, it got too cold, or the sensor stopped and no one noticed. Each of the three is a shipped rule, evaluated on every reading.
The fridge went above the band
A reading rises above the upper limit set for that store — a door left open, a failed compressor, or a power cut on a hot afternoon in Dar.
An excursion alert naming the fridge, the reading and the time, so the pharmacist can act before the batch is compromised.
Move stock to a working unit and keep the alert with its timestamps as the record of exactly how long the excursion lasted.
The fridge went below the band — the failure people forget
A reading falls under the lower limit. Many vaccines and biologics are ruined by freezing, and a fridge set slightly too cold does it quietly, with no visible sign.
A freeze alert, treated with the same weight as an over-temperature one — because a frozen vial looks identical to a good one.
Quarantine the affected stock and adjust the set point, rather than dispensing a product that has silently lost potency.
The probe stopped reporting
A probe goes quiet — a flat battery, a pulled cable, or a gateway that lost signal. The danger is the gap it leaves in the record.
An offline flag against that sensor, so the blind spot is visible now rather than discovered later as a hole in an audit.
Restore the probe and note the gap honestly — a missing stretch shown as "no reading", never back-filled with an invented value.
Storage records for a GSDP inspection
Tanzania's Medicines and Medical Devices Authority expects distributors and pharmacies to store medicines within a defined range and to be able to show they did. These are the pieces of that story Trakora produces.
A continuous temperature history
Live charts and a stored reading log per fridge and cold room, so the question "was it in range last month" is answered from the record, not from memory.
/ live-chartsExcursions, timed and named
Every over- and under-temperature event is captured with its start, its reading and the store it happened in — the detail a GSDP inspector asks for.
/ thresholdsA compliance report to hand over
A per-store, per-period report you can attach to an inspection or a distribution audit, rather than exporting raw numbers into a spreadsheet.
/ compliance-reportsHonest gaps, not invented data
When a sensor drops, the record shows the outage instead of guessing a value — which is what makes the rest of the record credible.
/ temp-monitoringSetting up a pharmacy store
From a probe in the fridge to a report you can hand an inspector.
Place a probe in each unit
Every fridge and cold room gets a temperature probe reporting to the gateway, with humidity charted alongside where the sensor supports it.
Set the band per product
The upper and lower limits are configured for what the store holds — a 2–8 °C fridge and a colder unit do not share one threshold.
Watch excursion, freeze and offline
Readings are checked continuously; too warm, too cold and sensor-offline each raise their own alert to SMS, WhatsApp and push.
Produce the compliance report
The history and every excursion are pulled into a per-store report for a GSDP inspection or a distribution audit.
What this cannot do
What to expect
- Trakora is a monitoring and compliance-record platform, not a certified medical device. It records and alerts on temperature; it does not replace a calibrated reference thermometer or the regulator's own verification of your equipment.
- The temperature band and the reporting interval are configured per product and per store and are marked as figures to be confirmed here — they are not fixed defaults in the module, so no value is stated as fact.
- Humidity is monitored and charted only. The module ships no humidity alarm rule, so this page does not claim one; if a humidity threshold is needed, ask whether it can be configured for your deployment.
- Alerting depends on the probe and gateway reporting. The sensor_offline flag exists precisely because a sensor can drop; a reading missed during an outage is shown as a gap, not reconstructed.
- Readings report over GSM, so in a coverage dead zone they buffer and backfill with their original timestamps when signal returns, rather than appearing in real time.
Values marked — are figures to be confirmed: the temperature band and the reporting interval are tuned per product and per deployment and are not fixed defaults in the module manifest, so no value is stated here as fact. Accuracy and calibration figures depend on the sensor hardware and are not published on this page.
Frequently asked questions
Is Trakora a certified medical device?
No. It is a monitoring and compliance-record platform. It alerts on and records temperature, but it does not replace a certified measuring instrument or a calibrated reference thermometer.
How does it help with a TMDA GSDP inspection?
It keeps a continuous temperature history per fridge and cold room, records every excursion with its time, and produces a per-store compliance report you can hand over.
Can a medicine be ruined by being too cold?
Yes. Many vaccines and biologics are damaged by freezing, so temp_below_threshold is treated with the same weight as an over-temperature excursion.
What happens to my record when a sensor drops?
A sensor_offline alert flags the outage and the record shows the gap as "no reading". The missing stretch is never back-filled with an invented value.
Do you monitor humidity too?
Humidity is monitored and charted where the sensor supports it. The module ships no humidity alarm rule, so we do not claim a humidity alert exists.
What temperature band do you use?
The band is set per product and per store — a fixed number is not published here because it is not a default in the module; it is configured for what each unit holds.
More in cold chain
Prove your pharmacy cold chain
Tell us how many fridges and cold rooms you run and we will scope monitoring in TZS, with a TRA-EFD VAT invoice and Swahili support.